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Closed (no longer recruiting)Last updated: 2 February 2024

This phase I/II trial is evaluating a new type of immunotherapy, known as a neoantigen cancer vaccine, in combination with two established immunotherapies, as a treatment for several different types of cancerAn International Phase 1/2 Study of GRT-C901/GRT-R902, a Neoantigen Cancer Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors

Clinical summary

Conditions

This trial is treating patients with non-small cell lung cancer, colorectal cancer, gastro-oesophageal cancer or urothelial cancer.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Gritstone Oncology, Bristol-Myers Squibb (BMS)

Scientific Title

An International Phase 1/2 Study of GRT-C901/GRT-R902, a Neoantigen Cancer Vaccine, in Combination With Immune Checkpoint Blockade for Patients With Advanced Solid Tumors

Eligibility

Inclusion

  • Provide a signed and dated informed consent form prior to initiation of study-specific procedures.
  • Patients with the indicated advanced or metastatic solid tumor as follows:

    1. NSCLC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy (note: patients who have received anti-PD-(L)1 monotherapy are eligible)
    2. GEA who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
    3. mUC who are planned for or have received no more than 1 cycle of systemic treatment with cytotoxic, platinum-based chemotherapy
    4. CRC-MSS who are receiving first line systemic therapy or who are planned for or have received no more than 1 cycle of second line systemic therapy including a fluoropyrimidine and oxaliplatin or irinotecan
  • 18 years of age or older
  • ECOG Performance Status 0 or 1
  • Lesion amenable to biopsy
  • Measurable disease according to RECIST v1.1
  • Have adequate organ function, as measured by laboratory values (criteria listed in protocol)

Exclusion

  • Tumors with genetic characteristics as follows:

    1. For NSCLC, patients with a known genetic driver alteration in EGFR, ALK, ROS1, RET, or TRK
    2. For CRC and GEA, patients with known MSI-high disease based on institutional standard
    3. For CRC, patients with a known BRAF V600E mutation or patients with peritoneal carcinomatosis and for GEA, patients with peritoneal carcinomatosis as their only evidence of disease
  • Patients with known central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Known exposure to chimpanzee adenovirus or any history of anaphylaxis in reaction to a vaccination or allergy or hypersensitivity to study drug components
  • Bleeding disorder (eg., factor deficiency, coagulopathy) or history of significant bruising or bleeding following IM injections or blood draws

Complete inclusion and exclusion criteria are listed in the clinical study protocol.

Inclusion

  • Your cancer has spread to other parts of the body.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

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